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ML4-20-D

by GE Parallel Design, Inc.

Ref 5838850Model ML4-20-D

ML4-20-D (5838850) is a device classified as Class IIa in the EU and Class II in the US made by GE Parallel Design, Inc., registered in EUDAMED on 9 Apr 2024 (Basic UDI-DI 8406821BUG00337HJ), cleared under FDA 510(k) K211524 on 27 Aug 2021 and listed in FDA GUDID since 18 Nov 2021 (UDI-DI 00195278002723), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K211524

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number8406821BUG00337HJ Basic UDI-DI 00195278002723UDI-DIDate9 Apr 2024RegisteredStatusActive
European UnionCE/MDR EUDAMED Number8406821BUG00337HJ Basic UDI-DI 00195278002723UDI-DIDate9 Apr 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00195278002723 UDI-DI Date18 Nov 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK211524 Date27 Aug 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 8406821BUG00337HJ registered 9 Apr 2024 Active· +1 more in the status table
  • FDA 510(k) K211524 decided 27 Aug 2021 Active
  • FDA GUDID UDI-DI 00195278002723 listed 18 Nov 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K211524
  2. Listed FDA GUDID 00195278002723
  3. Registered EUDAMED 8406821BUG00337HJ

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Extracorporeal ultrasound imaging transducer, hand-held
Device name
ML4-20 probes family
Model / Ref / Catalog
5838850, ML4-20-D
Primary DI / UDI-DI
00195278002723
Basic UDI-DI
8406821BUG00337HJ, B-00195278002723
510(k) Number
FDA product code
ITX, IYO, IYN
EMDN code
Z110402010101, Z110402010302
GMDN term
Extracorporeal ultrasound imaging transducer, hand-held
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1570, 892.1560, 892.1550
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
France
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000009295
Authorised representative
GE Medical Systems SCS FR-AR-000000344

Related devices

Category: Extracorporeal ultrasound imaging transducer, hand-held

Similar devices in this category

Other devices filed under TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES.

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Properties

  • Prescription use
  • Serial number
Other properties (23, all answered No)